Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

JOB SUMMARY
The Quality Associate II - Operations is responsible to provide QA support real-time for GMP Manufacturing of drug product. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed. Real time continuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory and industry standards, needed quality improvements, and safety/efficacy for phase appropriate GMP manufacture of drug products.

JOB DUTIES

• Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices
• Review executed Manufacturing Batch Records and supporting documentation for completeness, accuracy and compliance
• Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product
• Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions
• May participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc.
• Act as QA reviewer for deviations and CAPA issuance; with limited approval authority as designated by QA Management
• Perform Acceptable Quality Limit (AQL) visual inspection of drug product
• Participate in SOP revision as it pertains to process improvements
• Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary
• Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices

PROFESSIONAL SKILLS

• Exceptional organizational skills and attention to detail
• Ability to make risk based decisions and resolve issues with minimal guidance
• Excellent interpersonal skills and the ability to communicate well orally and in writing
• Proficiency in MS Office including Word, and Excel
• Excellent verbal and written communication skills required

EXPERIENCE

• Exposure to RCA, technical writing, and working with quality related investigations
• Exposure to lean operation excellence highly desirable
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
• Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks
• Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 preferred

EDUCATION

• Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 2-3 years of pharmaceutical or biotech industry experience with 1+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
• ASQ certification preferred

QUALITIES

• Ability to work in a dynamic, fast paced work environment
• Honesty, integrity, respect and courtesy with all colleagues
• Creative with the ability to work with minimal supervision and balanced with independent thinking
• Resilient through operational and organizational change

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

• Frequent reading, writing, and verbal communication
• Must be able to travel between multiple local production facilities
• Able to translate ideas to actual concepts and processes
• Proven ability to manage multiple projects (duties) simultaneously
• Able to work in a highly complex environment with competing demands and priorities

COMMUNICATIONS & CONTACTS

• Cross functional staff, members of management, internal and external clients, members of the Quality organization

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

• No managerial responsibilities. This is an individual contributor role.

#LI-LL1

Join us and be part of building the bridge between life changing therapies and patients.

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.